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510(k) K191737

The Graft Bone Substitute by Purgo Biologics, Inc. — Product Code NPM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2020
Date Received
June 28, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Animal Source
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.

Other clearances by Purgo Biologics, Inc.

  • K230305 — THE Graft Collagen (July 24, 2024)
  • K230091 — THE Cover (October 6, 2023)
  • K222549 — OpenTex (May 11, 2023)
  • K180992 — Biotex (July 16, 2019)
  • K173188 — The Graft Natural Bone Substitute (July 20, 2018)

Other clearances for product code NPM

  • K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (July 11, 2025)
  • K251613 — SwissGraft X (June 26, 2025)
  • K242510 — Geistlich Bio-Flow® (March 7, 2025)
  • K240133 — Xenograft Bovine Bone Particulate (August 16, 2024)
  • K230305 — THE Graft Collagen (July 24, 2024)
  • K240661 — Geistlich Bio-Oss® (July 12, 2024)
  • K231672 — S1 (October 13, 2023)
  • K221808 — InterOss Collagen (March 18, 2023)
  • K211551 — Wishbone HA (August 20, 2021)
  • K202183 — Porcine Mineral Collagen Composite (April 2, 2021)